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CastleVax Inc. Receives BARDA Project NextGen Award Valued at up to $338 Million to Advance Intranasal NDV-based COVID-19 Booster Vaccine into Phase 2b Clinical Efficacy Testing
CastleVax Inc. Receives BARDA Project NextGen Award Valued at up to $338 Million to Advance Intranasal NDV-based COVID-19 Booster Vaccine into Phase 2b Clinical Efficacy Testing
Interim results show that intranasal delivery resulted in a robust S-specific, secretory IgA response in saliva relative to pre-booster levels, which is important for conferring mucosal immunity and has the potential to prevent infection and/or transmission of COVID-19.
The Patria® vaccine generates antibodies similar to a vaccine approved by the WHO according to the data available from the Final Stage of Clinical Development, as a booster vaccine.
To date, no serious adverse events related to the application of the vaccine have been observed in the volunteers participating in the protocol; however, research continues to confirm the safety shown since the earlier phases of clinical development.
Information on the clinical advances in the development of Patria® has been shared and will be shared in strict adherence to regulatory processes and national and international standards. The results will be published in peer-reviewed scientific journals upon completion of the protocols that support the robustness of the data obtained.
The industrial scale of the Patria® production processes is accelerated with the aim of obtaining the authorization of the industrial production plants and the vaccine.
Mr. Anutin Charnweerakul, Deputy Prime Minister of Thailand and the Minister of Public Health announces that GPO’s NDV-HXP-S COVID-19 vaccine candidate (HXP-GPOVac) has entered phase 3 clinical evaluation as a booster dose at Nakhon Phanom Hospital in Nakhon Phanom Province on 20th December 2022. The study is recruiting 4,000 volunteers 18 years of age and older, who were immunized with 2 doses of COVID-19 vaccine as a primary vaccination.
The Mount Sinai Health System in New York, NY, has launched CastleVax, Inc. (“CastleVax”), a clinical-stage vaccine research and development company. CastleVax is devoted to the commercial development of the Newcastle disease virus (NDV) vaccine platform technology originally developed in the laboratories of Peter Palese, PhD; Adolfo García-Sastre, PhD; and Florian Krammer, PhD, at the Icahn School of Medicine at Mount Sinai.
Here we evaluated a vaccine candidate based on a live recombinant Newcastle disease virus (NDV) that expresses a stable version of the spike protein in infected cells as well as on the surface of the viral particle (AVX/COVID-12-HEXAPRO, also known as NDV-HXP-S). We evaluated this vaccine candidate in prime-boost regimens via intramuscular, intranasal, or intranasal followed by intramuscular routes in an open-label non-randomized non-placebo controlled phase I clinical trial in Mexico in 91 volunteers.
Reuters "Future of Health" coverage: A COVID-19 vaccine that can be produced locally in low and middle-income countries is yielding promising results in early clinical trials.
Secondary analysis of GPO / Thai Phase 1 trial results. NDV-HXP-S was compared to Pfizer and showed RBD (Receptor Binding Domain) focused response, and higher ratio of neutralizing to non-neutralizing antibodies compared to Pfizer.
Phase 2 trial results of NDV-HXP-S in Vietnam via the Institute of Vaccines and Medical Biologicals (IVAC). Results show higher concentration of neutralizing Ab in NDV-HXP-S group compared to AstraZeneca group. Phase 3 in planning.